This course is an intensive two days pharmacovigilance training course with focus on GVP guidelines. The course will elaborate from current and draft GVP guidelines and system changes from the EMA implemented during 2018.

The course will elaborate on how these changes will affect the day-to-day pharmacovigilance operations within the pharmaceutical companies with practical examples, which will be based on real life situations regarding electronic transmissions, signal management and organizational aspects affected by new draft GVP modules and the EMA’s system changes.

LEARNING OBJECTIVES

  • Expand your global safety knowledge
  • Apply legislation to ensure compliance
  • Submit compliant ADR data and avoid delays
  • Increase the accuracy of your causality assessment
  • Prepare for advanced crisis management control
  • Implement e-Submission strategies for ADR tracking & reporting

WHO SHOULD ATTEND

This course is valuable to professionals in drug safety with at least two years of experience, who wish to update their skills and enhance their knowledge by in- depth analysis of practical challenges and learn to implement solutions within ever changing pharmacovigilance environment:

  • Pharmacovigilance Professionals
  • Regulatory Affairs Specialists
  • Drug & Product Safety Associates
  • Medical Information Officers
  • Clinical Safety Specialists
  • Medical Affairs Specialists
  • Data Management Officer

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CANCELLATIONS: Confirm your cancellations in writing 3 weeks before the date and receive a 50% refund. Should you cancel between this date and 1 week before the date of the course regrettably you will not receive a refund. Customer may reschedule a booking to another date at a 100% rescheduling fee by advising Rephine Balticum of such rescheduling in writing. It may be necessary for reasons beyond the control and the organiser to alter the content and timing of the program or the identity of the trainers. In the unfortunate event that an event is cancelled Rephine Balticum are not liable for any costs incurred by delegates in connection with their attendance. This contract is subject to Latvian Law.